Principal Software Engineer - Compliance Lead

Principal Software Engineer - Compliance Lead Twin Cities, MNAbout the Opportunity An innovative medical technology company is seeking a Principal Software Engineer focused on expanding a breakthrough, non-invasive therapeutic technology into new clinical applications. This team functions as a startup in the broader established organization currently in a rapid prototyping phase.

Throughout prototyping, the software architect utilized AI code generation techniques with manual review and editing to develop a functional codebase for their current prototype. In this role, you would work closely with the architect to assess the existing code and develop a strategy towards FDA software compliance, including ownership of the relevant documentation and leading verification/validation activities.

This is a hands on position that may allow for technical leadership as the team grows to support clinical trials and commercialization. This is a great chance for senior engineers to work with a passionate group and build upon previous commercial success within a fast-paced, cutting-edge environment targeting new indications.

What You'll DoSoftware Compliance & Lifecycle Management Assess software systems against IEC 62304 requirements and define software safety classifications.

Perform gap analyses and establish compliant software development processes.

Author and maintain key software lifecycle documentation, including:
Software Development Plans (SDP)
Software Requirements Specifications (SRS)
Software Architecture Descriptions (SAD)
Software-level DFMEA documentation

Develop and maintain requirements traceability throughout the software lifecycle.

Partner with Quality and Regulatory Affairs teams to ensure documentation supports global regulatory submissions.

Serve as the subject matter expert for software lifecycle compliance and design controls. Risk Management, Verification & Validation Lead software risk management activities in accordance with ISO 14971 and IEC 62304.Define and maintain software verification and validation strategies.

Establish traceability between requirements, testing activities, and objective evidence.

Review software test strategies covering unit, integration, and system-level verification.

Oversee defect management, regression testing, and software release qualification activities.

Collaborate with Human Factors and Safety teams to identify and mitigate software-related risks. Technical Leadership & Architecture Define software architecture and technical roadmaps supporting future product and clinical expansions.

Drive critical decisions related to scalability, maintainability, cybersecurity, and system design.

Collaborate with systems, clinical, product development, and scientific teams to translate requirements into software solutions.

Evaluate development frameworks, technology stacks, and emerging tools that enhance product quality and engineering efficiency.

Program & Project Leadership Own software development plans, milestones, and deliverables aligned with broader program objectives.

Identify technical risks, dependencies, and mitigation strategies.

Coordinate external software development partners and vendors while ensuring compliance with design control requirements.

Communicate progress, risks, and recommendations to leadership and executive stakeholders.

Required Qualifications Bachelor's degree in Software Engineering, Computer Science, Electrical Engineering, or a related field.
10+ years of software development experience, including at least 5 years in regulated medical device environments.

Deep expertise with IEC 62304 and medical device software development lifecycle processes.

Hands-on experience developing and maintaining software compliance documentation.

Direct experience with software risk management under ISO 14971.Proven leadership of software verification and validation activities.

Strong software architecture and systems design experience.

Familiarity with integrating modern AI-enabled development tools into engineering workflows.

Experience leading technical deliverables within complex, cross-functional organizations.

Excellent written and verbal communication skills, including the ability to create regulatory-quality documentation and influence technical decisions.

Preferred Qualifications Experience establishing software processes from early-stage product development through commercialization.

Background in capital equipment, image-guided therapies, surgical technologies, or interventional medical…